UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SAXAGLIPTIN IN API AND PHARMACEUTICAL DOSAGE FORM
Keywords:Saxagliptin, UV spectrophotometer, Method validation, Methanol
Objective: A new sensitive, economical, simple, rapid UV spectrophotometric method has been developed for the estimation of Saxagliptin in API and pharmaceutical formulation.
Methods: Calibration curve method was used for the estimation of Saxagliptin in API and pharmaceutical formulation.
Results: The method was validated for linearity, range, accuracy, precision, robustness, LOD, LOQ. Linearity was found in the range of 10-60µg/ml. Accuracy was performed by using a recovery study. The amount of drug recovered was found to be in the range of 99.01-100.1%. All the parameters were validated as per the ICH guidelines.
Conclusion: This method is suitable forused routine analysis of present Saxagliptin in API and Pharmaceutical dosage form.
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